Position Summary

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC, in the United States, and its subsidiary, Kashiv BioSciences Private Limited, in India (together “Kashiv BioSciences”) operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

The Quality Assurance Specialist is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, in Piscataway, NJ. This employee will be responsible for supporting Kashiv BioSciences Quality Assurance management in reviewing, implementing, and managing the quality system to ensure overall product and process quality. As an integral quality team member, this individual will provide assurance that all products and quality system processes in the facility are in compliance with cGMP requirements and company policies and procedures. Assists in the direction and training of other quality team members.

Position involves reviewing and assembling batch documentation, issuing and tracking controlled documents, reviewing raw material documentation and releasing material, reviewing deviations, CAPAs, chance controls, validation/qualification, facility preventive maintenance, and calibration records. Position also involves the completion of manufacturing clearance activities to ensure requirements are met prior to and upon completion of manufacturing activities, and to serve as the witness for critical steps in manufacturing records and quality control documents.

Essential Duties & Responsibilities:

• Manage a broad spectrum of projects to support the needs of Quality Management.
• Issue, assembly, and review of documentation supporting batch, laboratory, warehouse, metrology, engineering, and validation activities, to ensure complete and in compliance with company policies and procedures and cGMP requirements. Quality system documentation to include SOPs, deviation/investigation reports, equipment/system qualification protocols and reports, change controls, as well as document control activities (training records entries, logbook issuances, logbook archival, etc.)
• Interface with cross-functional departments. Perform quality assurance walk-through audits of manufacturing, laboratory, and warehouse areas to ensure compliance with CGMPs and company procedures.
• Quality support of environmental/quality monitoring and release of controlled systems and environments. Support includes data review for release and support of  investigation activities.
• Assist and provide input as part of a project team to resolve quality and manufacturing issues and identify and implement corrective and preventive actions in a timely manner.
• Perform Raw Material, water, and gas sampling, In-process and Finish Product sampling, and coordinate submission of samples to QC analysis.
• Receiving external samples and logging into the internal quality system
• Quality release of raw materials and finished products.
• Provide backup for other Quality Assurance Specialist responsibilities. Perform other duties and responsibilities as delegated by Quality Management.
• Ensure adherence to GMP good documentation practices
• Complies with all company policies and standards

Position Requirements and Qualifications

Minimum Qualifications:

Education:

• A 4-year Bachelor's degree, preferably in a science or engineering discipline

Experience:

• Previous experience for QA I (0 to 2 years or more), QA II (2 to 5 years or more), and QA III (5 plus years) in a cGMP biologics/biosimilars manufacturing laboratory environment is required.
• Working knowledge of cGMP regulations (21 CFR210/211/820) is desired.
• Working knowledge of Deviation, CAPA, Change Control, and Validation/Qualification (IQ/OQ/PQ) is desired.
• Certification from professional organizations such as ASQ and ISPE is desired but not required.

Preferred Qualifications: 

SPECIALIZED KNOWLEDGE AND SKILLS: 

• Good communication skills, both written and verbal.
• Good organizational skills and detail-oriented. Must be able to effectively manage time to complete assignments.
• Excellent computer skills in Microsoft Office applications.
• Ability to work independently or in teams both within the department and cross-functionally. Must be able to organize, plan, and manage assigned tasks to bring projects to completion.
• Direct experience in manufacturing QA support (sampling, room/line clearance, cleaning verification) preferred
• Understand the requirements and procedures related to document control and Quality Assurance.
• Experience in GMP document control 
• Must be able to utilize technical information appropriately to ensure documents produced are consistently clear, concise, accurate, and complete.

Compensation:

• QA I Specialist – Base Salary Range and Yearly Bonus (0–2 years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $70,000 to $75,000 (dependent on years of experience and fit for the position) with up to a 8% yearly (discretionary) cash bonus
• QA II Specialist - Base Salary Range and Yearly Bonus (2-5 years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $80,000 to $85,000 (dependent on years of experience and fit for the position) with up to a 8% yearly (discretionary) cash bonus
• QA III Specialist - Base Salary Range and Yearly Bonus (5 plus years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $90,000 to $95,000 (dependent on years of experience and fit for the position) with up to a 8% yearly (discretionary) cash bonus

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

• Typing, desk work, and plant auditing.
• Must be able to read, write, and understand English.
• Manufacturing clean rooms. Some brief and/or minimal exposure to hazardous chemicals may occur, requiring personal protective equipment.
• Safety alertness is required due to working around hazardous equipment and conditions.
• General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines.

Supervisory Responsibility, if any: No

This position description is not a complete list of all responsibilities, duties, or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

Kashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.